Celgene Corporation - [2012] APO 12

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Celgene Corporation [2012] APO 12

Patent Application: 2011100687

Title:A method of treating a patient

Patent Applicant:  Celgene Corporation
Delegate:  Dr S.D.Barker
Decision Date:  17 January 2012
Hearing Date:  28 November 2011, in Melbourne
Catchwords:  PATENTS – examiner objections –lack of novelty as a “prescription approval code” is considered to be the same as a “prescription approval” – lack of innovative step – claims directed to a method of dispensing thalidomide are not a manner of manufacture – claims to a method including the step of administering thalidomide would not be a manner of manufacture as the essence of the invention does not lie in the useful arts – opportunity to amend

Representation: Patentee: Mr Warwick Rothnie of counsel, assisted by Mr James Cherry, patent attorney of Freehills Patent & Trade Mark Attorneys

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2011100687

Title:A method of treating a patient

Patent Applicant: Celgene Corporation
Date of Decision: 17 January 2012
DECISION
Three grounds for revocation have been made out.

The invention of claims 1 and 3 – 5 lacks novelty.

The invention of claims 1 – 5 lacks innovative step.

The invention of claims 1 – 5 is not a manner of manufacture.

I allow the patentee the remainder of the period for certification to propose amendments to remove the grounds for revocation.
REASONS FOR DECISION

Innovation patent 2011100687 (the patent) was filed by Celgene Corporation on 7 June 2011. The patent was sealed on 30 June 2011. The patent is a divisional application from innovation patent 2010101328 (the parent patent), which itself is a divisional application from innovation patent 2010100294 (the grandparent patent). Both the parent and grandparent patents ceased under section 143A due to failure to gain certification within the time prescribed by regulation 9A.4.
The Commissioner decided that it was appropriate to commence examination of the patent pursuant to section 101A, and an examination report issued on 29 August 2011. That report raised grounds for revocation that had been raised during examination of the parent and grandparent patents. The examiner issued two further reports in response to submissions and proposed amendments provided by the patentee. The Commissioner decided that it was appropriate to set the matter for hearing, and the patentee requested to be heard orally. A hearing was conducted on 28 November 2011 in Melbourne. The patentee was represented by Mr Warwick Rothnie of counsel, and Mr James Cherry, patent attorney with Freehills Patent & Trade Mark Attorneys.
1 The patent
The patent is titled “A method of treating a patient”. The specification states that some pharmaceuticals with useful activity are known to have adverse side effects in some members of the population. Thalidomide is known to cause birth defects, but also has useful activity in the treatment of erythema nodosum leprosum (ENL). The essence of the patent is summarised in the Abstract filed with the specification on 7 June 2011:
“The present invention relates to improved methods for delivering a drug such as thalidomide to a patient while reducing the risk of the occurrence of an adverse side effect known or suspected of being caused by the drug. The methods permit the distribution to patients of these drugs, in ways wherein such distribution can be carefully monitored and controlled.”
The key way in which distribution is monitored and controlled is through the use of a prescription approval code, as stated on page 4 of the specification:
“The present invention is directed to a method of treating a patient with thalidomide by permitting a prescription for thalidomide to be filled by a pharmacy only after a prescription approval code has been communicated to the pharmacy to authorise the dispensing of thalidomide to the patient”
The prescription approval code is only communicated to the pharmacy if certain criteria are met. At page 5 those criteria are broadly described as:
“the patient, prescriber and pharmacy are registered in the medium; and
the risk of an adverse side effect occurring in the patient for this presentation is acceptable”
The key features of the method that is described in the patent are
- registration of the prescriber, pharmacist and patient (in a computer readable storage medium);
- an assessment of acceptable risk; and
- a prescription approval code
1.1 Registration of the prescriber, pharmacist and patient
The process that is described is based on the assumption that the prescriber, pharmacist and patient are registered in the system. If any party is not registered, then the thalidomide cannot be dispensed. For instance, at page 23 the specification says:
“If the prescriber is not registered in the computer readable storage medium, the prescriber will be ineligible to prescribe the drug. Similarly, if the pharmacy is not registered in the computer readable storage medium, the pharmacy will be ineligible to dispense the drug.”
The specification does not explain how compliance with this arrangement is enforced.
1.2 Acceptable risk
The specification states at many points that registration of patients is based on completion of a questionnaire on risk issues. For instance, at page 14 the specification states:
“The type of information that is gathered from the patient will depend on the preconditions that need to be fulfilled before a prescription approval code is issued.”
The risk factors that would be considered are matters that are already known in the art. At page 15 the specification says:
“As will be evident to those skilled in the art, the risk parameters to be considered and the risk groups defined by those parameters will be based upon factors which influence the risk that a known or suspected adverse side effect will occur if a patient receives the drug, and will vary depending upon the drug in question. Where the drug is a teratogenic drug, for example, such risk parameters may include elements which would impact the risk of a foetus and/or female of child bearing potential being exposed to the drug, such as the age, sex and reproductive status of the patient. For example, a first risk group may comprise female patients of child bearing potential; a second risk group may comprise female patients of non-child bearing potential; a third risk group may comprise sexually active male patients; and a fourth risk group may comprise sexually inactive male patients. Preferably, the risk group is female patients of child bearing potential.”
Based on the risk group assigned to a person, they may be precluded from approval for dispensing the drug (page 17). However, the specification indicates a preference for providing the patient with information regarding the risks associated with the drug. At page 17 – 18 the specification states:
“Preferably the patient is provided full disclosure of all the known and suspected risks associated with taking the drug. For example, in the case of teratogenic drugs, the prescriber preferably counsels the patient on the dangers of exposing a foetus, either one which may be carried by the patient or one carried by a recipient of the bodily fluids of the patient, to the teratogenic drug. Such counsel may be provided verbally, as well as in written form. In preferred embodiments, the prescriber and/or pharmacist provides the patient with literature materials on the drug for which a prescription is contemplated, such as product information, educational brochures, continuing education monographs, and the like. Thus, in the case of methods involving teratogenic drugs, the prescriber and/or pharmacist preferably provides patients with literature information, for example, in the form of the aforesaid product information, educational brochures, continuing education monographs, and the like, warning the patient of the effects of the drug on foetuses. In the case of other drugs which are known or suspected of causing an adverse side effect, the patient is counselled as to the dangers of taking the drugs, and if steps which may be taken to avoid those risks. For example, if the concomitant use of the drug and another drug, for example alcohol, is to be avoided, the prescriber and/or pharmacist advises the patient of the risks of drinking alcohol while taking the drug.”
The result of the information provided to patients is that they are able to provide informed consent.
1.3 The prescription approval code
The nature of the prescription approval code is not stated in the specification. Consequently I have attempted to draw inferences from the role that it plays. The code is “associated with the presentation by the patient of the prescription” (page 4). It is not clear that this represents anything more than that the prescription approval code is produced in response to the enquiry from the pharmacist. The prescription cannot be filled unless a prescription approval code is provided, giving the prescription approval code a gatekeeper role. From this I conclude that anything that could reasonably be seen as indicating approval can be seen as an approval code.
The specification contains a single example, which does not shed any light on the approval code. The example is based on the assumption that the prescriber, pharmacist and patient are all registered in the system. The part of the example says (at page 28):
“Once the script is verified by the RMC [the RMC is a Risk Management Center, which is defined on page 12 as “a centralised collection of information that manages the risk of adverse side effects known or suspected of being caused by the drug”] a prescription approval code is assigned to the prescription by the RMC. The prescription approval code is then provided to the pharmacist, who may then dispense thalidomide to the patient.
If a prescription approval code is not provided to the pharmacist, the pharmacist will notify the patient and/or prescriber.”
I conclude that the prescription approval code is anything that could reasonably be seen as indicating approval.
1.4 What is the outcome of the method?
The method described in the patent is a variation on the existing method of dispensing thalidomide. However, it is not immediately clear what is achieved (in terms of a different outcome) by following the method of the patent. The following is a sample of statements that appear in the specification that are relevant to this issue:
“the Australian Therapeutic Goods Administration (TGA) has approved an application by Celgene Pty Limited to market thalidomide for the treatment of erythema nodosum leprosum (ENL) and multiple myeloma in specified circumstances” (page 3)
“due to the severe teratogenic risk of thalidomide, methods are needed to control the distribution of this drug so as to preclude administration to foetuses” (page 3)
“an improved survey is needed which would be representative of all users of a particular drug, such as thalidomide and lenalidomide” (page 4)
“the present invention is directed to a method of treating a patient with thalidomide by permitting a prescription for thalidomide to be filled by a pharmacy only after a prescription approval code has been communicated to the pharmacy” (page 4)
“the methods described herein provide advantageous and effective means for monitoring, controlling and authorizing the distribution to patients of drugs known or suspected of causing adverse side effects” (page 9)
“used to avoid exposure of foetuses to teratogenic drugs” (page 9)
“reducing or minimizing the possibility that a contraindicated individual will be exposed to the potentially hazardous drugs” (page 10)
“the methods of the present invention preferably involve requiring the patient to fill out an informed consent form” (page 19)
“by filling out and signing an informed consent form, the patient acknowledges that he/she understands the risks associated with the drug” (page 20)
“the methods described herein, provide a means to monitor and authorize distribution of contraindicated drugs, including teratogenic drugs” (page 26)
The claimed method appears to be directed towards several outcomes - reducing the incidence of a contraindicated patient taking thalidomide, reducing the incidence of a patient being unaware of the risks associated with thalidomide, and developing records of thalidomide use. The first is clearly relevant for patent purposes.
The risk associated with thalidomide being taken by a contraindicated patient is significant, due to the birth defects known to be associated with thalidomide. However, such an outcome is only possible if prescribers have been wrongly prescribing thalidomide. I can find no statement anywhere that suggests this is believed to be the case. Rather, the risk that is being referred to in the specification seems to be the “you can never be too safe” kind of risk. Consequently, as the specification provides no reason to believe that contraindicated patients are currently being prescribed thalidomide, the method of the invention will not lead to any patients being denied thalidomide. The difference between the method of the invention and the existing process is that there will be greater confidence that contraindicated patients will not receive the drug. However, it may be that the patentee has evidence of erroneous prescribing, and this could be inserted into the description.
Turning to patient information, it is apparent that as a result of the method patients may have a fuller understanding of the risks associated with thalidomide (and better able to give informed consent). For instance, the specification states at page 18 that male patients “are preferably counselled to use condoms every time they engage in sexual relations, since many teratogenic drugs may be found in semen”. However, the specification provides no reason to believe that patients are not being properly informed of the risks associated with thalidomide. In this case, the method of the invention will not lead to any patients receiving information that they would not otherwise possess. The difference between the method of the invention and the existing process is only that there will be greater confidence that patients have the necessary information. Similarly to what is said above, it may be that the patentee could insert further information into the description.
2 The claims
The specification contains five claims.
2.1 Claim 1
Claim 1 as presently proposed to be amended is as follows:
1. A method of treating a patient with thalidomide by permitting a prescription for thalidomide to be filled by a pharmacy only after a prescription approval code has been communicated to the pharmacy to authorise the dispensing of thalidomide to the patient and dispensing that thalidomide for administration to the patient, comprising the steps of:
upon presentation by the patient of the prescription to the pharmacy, consulting a computer readable storage medium in which the patient, a prescriber and the pharmacy are registered, each patient having a unique patient identification number assigned to the patient, and in which is recorded an assessment of whether the risk of an adverse side effect occurring in the patient is acceptable;
associating a prescription approval code with the presentation by the patient of the prescription for thalidomide upon verifying that:
the patient, prescriber and pharmacy are registered in the medium; and
the risk of an adverse side effect occurring in the patient for this presentation is acceptable; and
communicating the prescription approval code to the pharmacy.
There are several key questions to be addressed in order to construe this claim.
2.2 Is claim 1 directed to a method of treatment?
Claim 1 is a method, and methods are characterised by the steps of the method. Claim 1 says it is a “method of treating a patient with thalidomide”. Normally a method of treatment would include a step in which the thalidomide is consumed by the patient (an administration step), rather than merely dispensed to the patient (a dispensing step). Claim 1 does not include an explicit administration step, so should such a step be inferred? At the hearing the patentee’s representatives submitted that the claim should be viewed as not including a requirement that the thalidomide is administered, although they argued that it is the logical next step after dispensing.
The only clear reference to administration is in the passage “dispensing that thalidomide for administration to the patient”. This says only that the thalidomide is “for administration”, which stops short or actual administration. In this case I attach more significance to the explicit process steps in the claim, and less to the general language in the preamble to the claim. The claim does not include an administration step, and is more properly construed as a method of dispensing thalidomide.
2.3 What is the role of the prescription approval code?
The claim says that it is a method of
“permitting a prescription for thalidomide to be filled by a pharmacy only after a prescription approval code has been communicated to the pharmacy to authorise the dispensing of thalidomide to the patient”
The claim recites a number of steps for gaining a prescription approval code that are familiar from the description. The only role for the prescription approval code is to “authorise the dispensing of thalidomide”.
2.4 Claim 2
Claim 2 is appended to claim 1:
2. A method according to claim 1, wherein the prescription approval code is generated from a list stored in the computer readable storage medium.
The added feature is that the approval code is generated from a list stored in the computer readable medium.
2.5 Claim 3
Claim 3 is appended to either claim 1 or claim 3:
3. A method according to claim 1 or claim 2, wherein the prescription approval code is associated after it is also verified that the patient is not pregnant.
The added feature is that it has been verified that the patient is not pregnant.
2.6 Claim 4
Claim 4 is appended to any of claims 1, 2 or 3:
4. A method according to any one of the preceeding claims, wherein, when the patient is a female of childbearing potential, the prescription approval code is issued before the prescription is dispensed.
The added feature is that the approval code is issued before the thalidomide is dispensed. This would imply that claim 1 includes the possibility that the thalidomide is dispensed before the approval code is generated. However, this is inconsistent with the construction of claim 1, above. A construction whereby the process of claim 1 permits dispensing before approval is not reasonable. The more reasonable construction is that claim 4 adds nothing.
2.7 Claim 5
Claim 5 is appended to any of claims 1, 2, 3 or 4:
5. A method according to any one of the preceeding claims, wherein the method includes the further step of, upon presentation by a patient to a pharmacy of a prescription for lenalidomide to be dispensed for administration to the patient, requiring association of a prescription approval code, wherein the prescription approval code is associated only upon verifying that the patient is registered in the computer readable storage medium using the patient’s unique patient identification number.
Lenalidomide is a thalidomide derivative. The added features of this claim are that the patient also presents a prescription for lenalidomide. The lenalidomide is only dispensed if a prescription approval code for the lenalidomide is also obtained.
3 The objections
There are two objections raised in relation to the innovation patent. First it is objected that the invention is not a manner of manufacture (as required by section 18(1A)). Second, it is objected that the invention is anticipated by US 2007/0219825 – specifically claims 1, 3, 4 and 5 lack novelty and claims 1 – 5 lack innovative step. I will deal with the anticipation issues first.
4 Novelty

Section 7 of the Act states that an invention is taken to be novel unless it is not novel in the light of the prior art. A citation is part of the prior art base for the purposes of novelty if it was published before the priority date of the claim.
It is well established that the general test for lack of novelty is the reverse infringement test. The classic formulation of this test is that given by Aickin J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228 at 235:
“The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement”
This test is satisfied if the alleged anticipation discloses all the essential features of the invention as claimed (see Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 at 517). In order to meet this requirement, the prior art must “contain clear and unmistakeable directions to do what the patentee claims to have invented” (The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited [1972] RPC 457 at 486).
The examiner has maintained a novelty objection against claims 1 and 3 – 5 based on US patent application 2007/0219825 by Derek J. Maetzold and Terrance C. Coyne (the citation). The citation states on its face that it was published on 20 September 2007, which is before the earliest priority of the present patent (31 March 2010). Consequently the citation is prior art for the purposes of section 7.
The citation states at paragraph [0003] that it relates to
“methods for delivering a drug to a patient. More particularly, the methods restrict access to the drug to only those patients for which the risk that they will experience an adverse side effect is acceptable”
The way in which the citation achieves this end is explained in paragraph [0009] as
“a method for restricting delivery of a drug that provides a combination of some or all of the following elements: (i) a method for registering prescribers, patients, and pharmacies with a program to enable restricted distribution of the drug; (ii) a method for providing education and conselling to prescribers, patients, pharmacies, laboratories, and clinics who may need to interact with the patient during their drug treatment program, specifically related to the drug and the drug delivery method; (iii) a method for collecting and providing up-to-date patient-specific health information beyond what is collected in an office examination to enable a physician or others responsible for overseeing the drug treatment program to better manage the drug treatment program and minimize undesired side effects; (iv) a method for providing a secondary review of the patient’s health to help identify any risk factors in a patient to help prevent occurrence of adverse side effects; and (v) a drug service center to manage and ensure compliance with the above elements.”
It is step (i) of this method that is of particular significance in the present case. At paragraph [0011] the citation says:
“the generation of the prescription approval comprises providing a database, in which at least one prescriber, at least one pharmacy and the patient are registered; creating a patient profile in the database … enabling the at least one registered prescriber to access to the patient profile in the database … and upon a determination by the registered prescriber that the risk is acceptable, generating a prescription approval”
and then at paragraph [0012]
“wherein after the prescription approval has been generated, the at least one registered pharmacy is permitted to dispense the drug to the patient as ordered by the prescription”
The drugs envisaged include thalidomide (which is specifically named in paragraph [0024] of the citation). It is clear that there are substantial similarities between the method described in the citation and that in the innovation patent. The patentee’s written submissions provided prior to the hearing indicated that the following integers are missing from the citation:
“(a)the patent requires that the integers of consulting the computer readable storage medium, verification and association of the prescription approval code be triggered only on the patient presenting a prescription to the registered pharmacy
(b)the patent provides for the association of a prescription approval code with each presentation while Maetzold et al.:
(i) discloses only generation of an approval for release of the prescription; and
(ii) does not teach that a prescription approval must be generated each time a refill is required
At the hearing, Mr Rothnie focussed on the prescription approval code, so I will deal with that issue first. In the innovation patent the approval is a “prescription approval code”, whereas in the citation the approval is a “prescription approval”. Mr Rothnie submitted that a “prescription approval” could be as simple as a YES or NO response, whereas a “prescription approval code” is different. My understanding of the patentee’s submissions is that a code is a symbol or sign that represents a message, whereas the word YES is the message.
I have looked carefully at the specification of the innovation patent, but I can find no definition of the term “prescription approval code”, or an example of such a code. Consequently, the patentee’s argument depends upon their asserted meaning of “prescription approval code” being the normal and natural meaning of that term. The Macquarie Dictionary defines “code” as
“3. a system of symbols for use in communication by telegraph, heliograph, etc., as morse code. 4. a symbol (made up of signs, numbers, letters, sounds, etc.) in such a system. 5. a set of words, pictures or other readily recognised symbols used for conveying messages briefly, as road signs. 6. a system of arbitrarily chosen symbols, words etc. used for secrecy. 7. a system of symbols for conveying information or instructions to an electronic computer.”
In essence, a code is a representation of a piece of information. I have difficulty seeing why a word (such as YES) is not properly viewed as a code. Writing uses symbols (i.e. the letters of the alphabet) to create words that represent information. The coded nature of writing is apparent when a written message is given to a person who is illiterate. I believe that a YES or NO response can be regarded as a “prescription approval code”. However, if I am wrong in this view, there are two further matters that lead me to believe that a “prescription approval code” is the same as a “prescription approval”. First the signal sent to the computer at the pharmacy is not a YES, but an electronic signal that is decoded by the pharmacy computer as the word YES. The electronic signal is clearly a code. Second, YES is itself a shorthand (or code) for something like “you are authorised to dispense thalidomide to the person named in the prescription”. In either case a “code” is sent to the pharmacy.
The patentee’s written submissions indicated that the citation allows the drug to be dispensed without the presentation of a prescription. The submissions state:
“In contrast, Maetzold et al. contemplates that the pharmacy may dispense the drug on receipt of instructions from the prescriber or a drug service centre rather than on presentation of the prescription by the patient in the pharmacy.”
It is true that there are some passages in the citation that refer to embodiments where “this registration card or form may also serve as a request for a prescription for the drug” (para [0030]). However, it is quite clear that the citation is not restricted to this embodiment, and that it is directed generally to “permitting a prescription order to be filled by a pharmacy only after the pharmacy has received an approval” (see para [0010]). It is clear that the citation discloses a patient presenting a prescription to the pharmacy.
The patentee also submitted that the citation does not require an approval to be issued each time the drug is dispensed (i.e. it may not be required for a refill). The patentee’s written submission says:
“Some embodiments of Maetzold et al. appear to require that a prescription approval is obtained each time before the drug is dispensed. Other embodiments treat that as optional.”
The patentee acknowledges that there is a disclosure of requiring an approval each time a prescription is filled. The fact that some embodiments may treat this as optional does not remove the disclosure of those embodiments where it is obtained. This feature is clearly disclosed.
In the responses to the examiner’s reports there is a suggestion that a “prescription approval code” is only sent when approval is given, and is not sent when approval is denied, i.e. a NO signal is not sent. To my mind this is reading far too much into the bare words of both the innovation patent and the citation. I can find nothing in the specification that supports a view that a prescription approval code cannot include a NO response where approval is denied. There is nothing to suggest that such a distinction is real. It follows that I am satisfied that the difference between the citation and the innovation patent is semantic, and not a difference of substance.
Turning to claims 3 and 4, the features added by these claims are also disclosed in the citation. The feature of claim 3, that it is verified that the patient is not pregnant, is apparent on page 4 of the citation:
“Female patients preferably will also acknowledge that, at the time they are being prescribed the teratogenic drug, they are not pregnant. … female patients preferably agree to undergo pregnancy testing, before, during and after treatment with teratogenic drugs”
Claim 4 merely adds the feature that the prescription approval code is issued before the thalidomide is dispensed. This is clearly disclosed in the citation.
Claim 5 has the added feature that the patient also presents a prescription for lenalidomide. The lenalidomide is only dispensed if a prescription approval code for the lenalidomide is also obtained. The citation makes it clear that the method of the citation can be used for any drug “known or suspected of causing an adverse side effect” (page 2), although it does not specifically refer to lenalidomide. Lenalidomide is a drug “known or suspected of causing an adverse side effect”, as it is structurally related to thalidomide and treated as a potential teratogen. On balance of probabilities, I think it is clear and unmistakeable that the citation discloses that the process can be applied to lenalidomide. The use of the method of the citation for two drugs, i.e. both thalidomide and lenalidomide, would seem to be a case of following the instructions of the citation. I conclude that claim 5 is not novel.
5 Innovative step
Section 7 of the Act states that an invention is taken to involve an innovative step unless the invention would only vary from the prior art information in ways that make no substantial contribution to the working of the invention. The Federal Court has considered innovative step in Dura-Post (Aust) Pty Ltd v Delnorth Pty Ltd [2009] FCAFC 81, 81 IPR 480. At [73] – [74], 496 – 497 Kenny and Stone JJ state:
“Section 7(4) requires a comparison to be made between the invention as claimed in each claim with the information s 7(5) describes. That is, s 7(5) identifies the kinds of information to which the invention as claimed in each claim is to be compared. This information is particular kinds of prior disclosures. Section 7(6) requires that each such prior disclosure be considered separately. That is, the invention as claimed in each claim must be compared separately with each relevant prior disclosure.
In making this comparison, s 7(4) requires that each comparison be made from the perspective of a person skilled in the art, whose task is to identify and assess the variations between the invention as claimed in each claim and the prior disclosure and determine whether or not these variations make a substantial contribution to the working of the invention as claimed in each claim. Dura-Post accepted, as do we, that the primary judge was correct in holding that “substantial” contribution in the context of s 7(4) meant “real” or “of substance”. The place of common general knowledge in this provision is straightforward enough. Section 7(4) contemplates that, in performing this task, a person skilled in the art has certain background knowledge that that person uses in identifying and assessing these variations.”
The objection of lack of innovative step based on US 2007/0219825 (the same citation discussed above in relation to novelty) is directed to claims 1 – 5. In my consideration above I concluded that there is no variation between the invention claimed in claims 1, 3, 4 and 5 and the disclosure of the citation. It follows that as there is no variation, there can be no innovative step. Claim 2 is thus the only claim that needs to be carefully considered.
Claim 2 has the added feature that the approval code is generated from a listed stored in the computer readable medium. This feature is mentioned on page 5 of the description as follows:
“In one preferred embodiment, the prescription approval code is generated from a list stored in the computer readable storage medium.”
I have been unable to find any explanation in the specification of the contribution made by this feature. The single example does not demonstrate this feature, as “the prescription approval code is assigned to the prescription by the RMC” (page 28). The patentee’s written submissions state on page 20:
“The generation of a prescription approval code from a pre-existing list can and would be readily understood by the person skilled in the art to contribute important benefits.
For example, the use of a list can promote record keeping and tracking. Given the potentially severe consequences of improper administration of the drugs, these benefits are important contributions to the working of the claimed method and are properly considered ‘real’ or ‘of substance’.
There is no evidence before the Commissioner to the contrary.”
I am surprised that the specification does not suggest any benefits arising from this feature. The sole asserted benefit of promoting record keeping and tracking seems to flow from the use of a prescription approval code, rather than the fact that a list is stored in the computer readable storage medium. For instance, the specification indicates that the general method of the invention (as distinct from the invention defined by claim 2) provides effective means to monitor the distribution of thalidomide (see page 9). As a matter of logic, I cannot see that locating a list in the computer readable storage medium is anything other than a matter of convenience that does not make a substantial contribution to the working of the invention.
It follows that claim 2 lacks an innovative step. I am satisfied that the invention defined by claims 1 – 5 lacks an innovative step.
6 Manner of manufacture
Subsection 18(1)(a) provides that an invention is a patentable invention if, so far as claimed in any claim, it is “a manner of manufacture within the meaning of section 6 of the Statute of Monopolies”. The concept of manner of manufacture has developed over time, and is not readily reduced to a simple formula. The leading consideration of manner of manufacture is the decision of the High Court in National Research Development Corporation v Commissioner of Patents [1959] HCA 67, 102 CLR 252. The Court made the observation (at [14], 269) that it is necessary to look at the concept of what is patentable:
“The inquiry which the definition demands is an inquiry into the scope of the permissible subject matter of letters patent and grants of privilege protected by the section. It is an inquiry not into the meaning of a word so much as into the breadth of the concept which the law has developed by its consideration of the text and purpose of the Statute of Monopolies. … The right question is: ‘Is this a proper subject of letters patent according to the principles which have been developed for the application of s 6 of the Statute of Monopolies?’ ”
The existing case law provides examples of various subject matter that does, and does not, constitute a manner of manufacture. In National Research Development Corporation (hereafter referred to simply as NRDC) a method for eradicating weeds was held to be patentable subject matter. The Court laid down the well known requirement that a process must produce “an artificially created state of affairs” in order to be held patentable (at [25], 277). This formulation has been applied by the Federal Court in a number of cases. Of note is Grant v Commissioner of Patents [2006] FCAFC 120, 234 ALR 230 where the court at [30], 237 referred to “any artificial state of affairs, in the sense of a concrete, tangible, physical, or observable effect”. However, it is apparent that it is not just any effect that must be shown, the effect must be “material” (NRDC at [22], 275) or a “useful effect” (International Business Machines Corporation v Commissioner of Patents [1991] FCA 625, 105 ALR 388 at [14], 394). Insignificant physical effects will not be sufficient. For example, the Grant decision is a case where the claimed process produced a movement in the ownership of assets (which can be seen as an effect), but was not a manner of manufacture. Several recent Patent Office decisions discuss other physical effects which are considered insignificant. It is not necessary to consider these decisions, as the present case is of a different type.
In Bristol-Myers Squibb Co v F H Faulding & Co Ltd [2000] FCA 316, 170 ALR 439 the Federal Court held that methods of treatment of the human body are not inherently unpatentable. The majority at [15], 444 referred to “the insurmountable problem, from a public policy viewpoint, of drawing a logical distinction which would justify allowing patentability for a product for treating the human body, but deny patentability for a method of treatment”.
The examiner reported that claims 1 – 5 represent nothing more than a scheme, and consequently are not directed to patentable subject matter. The most recent objection was objection 5, which reads:
“Objection item 3 of the previous report is maintained. The application is not for a manner of manufacture within the meaning of Section 18(1A)(a) of the Patents Act 1990 because the subject matter of the amended claims 1-5 represents nothing more than a scheme, considered to be not patentable.
I note that the amended claim 1 includes the new feature of “dispensing that thalidomide for administration to the patient”. However, this feature merely represents dispensing of the drug thalidomide to a patient which is by nature suitable for administering to the patient. Therefore, this newly added feature is only considered to be mere dispensing of the drug thalidomide to the patient. Dispensing includes within its scope the pharmacist handing the thalidomide to the patient; this step is purely a working direction or method step that is not an artificially created state of affairs. Hence, this newly added feature does not make sufficient change in the scope of claim 1 to render claim 1 a manner of manufacture.
In the reply of 17 October 2011, page 1, you have mentioned that, “The claimed method is for treating a patient. It is not a scheme. It is a specific series of steps involving tangible subject matter defining an improvement on a treatment method. The outcome of the method is not mere information but dispensing of a tangible product to treat patients with a serious disease”.
However, as discussed in the previous report, while the pre-amble of the independent claim of this present divisional application has been changed to a method of treating a patient; the subject matter of the claims merely define a scheme for restricting the dispensing of the drug thalidomide to the patients. The whole specification of this application does not define any such feature which is directed to medical treatment of a patient per se; rather the application is directed to a method which merely checks various databases to verify whether the patient, the prescriber and the pharmacy are registered and upon associating a approval code a prescription of the drug thalidomide is approved. These steps again are performed by a person and therefore do not create an artificially created state of affairs and the method step(s) amount to no more than a scheme for dispensing a drug. Such schemes are not patentable under the manner of manufacture requirements.”

I have previously stated that the claims as presently proposed to be amended are directed to a method of dispensing thalidomide, rather than a method of actually treating a patient. Consequently, the Bristol-Myers Squibb case does not assist the patentee.
A method of dispensing thalidomide leads to an outcome where patients either have, or do not have, thalidomide in their possession. The mere possession of thalidomide causes no change in the patient. I cannot see how possession of an article can be regarded as an artificially created state of affairs. I note that possession and transfer of property was not a suitable effect in the Grant case, and I can see no reason why it should be so in this case. It follows that claims 1 – 5 are not directed to a manner of manufacture.
However, as it would be possible to amend the claims to insert an explicit method of treatment step I have considered whether such an amendment would overcome the manner of manufacture objection. For the purposes of the following discussion I have assumed that the claims can be amended to include a step of the form “and the patient takes the thalidomide” (I will refer to this as the hypothetical claims). However, the patentee could choose to amend (or not amend) in any manner they wish.
Without doubt, a patient who has had their disorder treated is an artificially created state of affairs (consistent with the Bristol-Myers Squibb case). However, it is clear that an artificially created state of affairs is a necessary, but not in itself sufficient, requirement for a patentable invention. This is obvious when it is remembered that traditionally excluded subject matter such as kits, printed matter, new use of a known substance, and even the fine arts all involve a man-made (and thus artificial) subject matter. Some insight into the approach to adopt is given in the NRDC case. At [22], 275 the Court said:
“The point is that a process, to fall within the limits of patentability which the context of the Statute of Monopolies has supplied, must be one that offers some advantage which is material, in the sense that the process belongs to a useful art as distinct from a fine art (see Re Virginia-Carolina Chemical Corporation’s Application [1958] RPC 35 at p 36) – that its value to the country is in the field of economic endeavour.”
This statement directs attention at the “advantage” of the process, rather than just the words of the claim. I do not believe that the meaning of “advantage” should be understood by reference to a dictionary. The High Court used the term in the context of the invention that they were considering: “it provides a remarkable advantage, indeed to the lay mind a sensational advantage, … consisting in an important improvement in the conditions in which the crop is to grow, whereby it is afforded a better opportunity to flourish and yield a good harvest.” ([25], 277). The Virginia-Carolina case to which the High Court referred put the concept in different terms at 37:
“In considering whether or not an application discloses a patentable invention, it is proper that attention should be directed to the alleged contribution to the art rather than the form of words tentatively put forward as defining the invention.
Considerable controversy has arisen in the past, as shown by decided cases, as to how broadly a new departure in an art could be claimed. Considerations arising from this aspect of the matter may serve to cloud the real issue of manner of new manufacture, so that, in principle, the best approach would appear to necessitate an examination of the application documents as a whole to discover what, if any, contribution it contained and then to pose the question: Can this contribution be expressed in language as constituting a means of manufacture?
In this way, applications containing some useful additions to the known methods of preparation of articles or materials will not be imperilled by injudicious claiming clauses nor will claiming clauses ostensibly directed towards a manner of manufacture cloak the real nature of the applicant’s disclosure.”
Both NRDC and Virginia-Carolina indicate that it is necessary to consider the invention as described, as well as the words of the claim. In both cases the courts sought to find the essence of the invention, a task that involved considering the “improvement”, the “contribution to the art” and “the real nature of the applicant’s disclosure”. These subjective considerations of the essence of the invention are the basis for deciding whether the claimed invention is a manner of manufacture.
In the present case the essence of the hypothetical claimed method is the checking of risk during the dispensing of thalidomide. However, no new risk factors are considered. All that is involved is double checking whether the original decision of the prescriber was correctly made, and confirming (or rejecting) that there is an acceptable risk associated with thalidomide treatment. This is analogous to a process of treating a patient characterised by the patient double checking the instructions on the bottle of tablets before taking a tablet. While this is clearly a sensible thing to do, the essence of the method clearly does not lie in the useful arts, or the field of economic endeavour. The hypothetical claims of the present innovation patent are similarly directed to a sensible thing to do, but the essence of the invention does not lie in the field of economic endeavour. I cannot see how the addition of an explicit treatment step could convert the method to a manner of manufacture.
7 Conclusion
I have found that the invention of claims 1 and 3 – 5 lacks novelty, and the invention of claims 1 – 5 lacks innovative step. I have also found that the invention of claims 1 – 5 is not a manner of manufacture. Consequently, several grounds for revocation have been made out, and those grounds of revocation have not been removed. Subject to section 101F(3), the patent “must” be revoked (see section 101F(1)).
According to section 101F(3):
The Commissioner must not revoke a patent under this section unless the Commissioner:
(a) has given the patentee a reasonable opportunity to be heard; and
(b)has, if appropriate, given the patentee a reasonable opportunity to amend the relevant specification for the purposes of removing a ground for the revocation of the patent and the patentee has failed to do so.
The patentee has had the opportunity to address the grounds for revocation identified in this decision. However, the detailed reasons in this decision are different to those in the examination reports. Consequently, the patentee has not had a reasonable opportunity to consider amendment in the light of the reasoning in this decision. While it is problematic whether the claims can be amended to overcome these grounds, I will allow the patentee the remainder of the period for certification to propose amendments to remove the grounds for revocation. However, any amendments must meet the normal allowability criteria of section 102.
Dr S.D.Barker
Delegate of the Commissioner of Patents